dexamethasone sodium phosphate


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dexamethasone sodium phosphate

Pharmacologic class: Glucocorticoid

Therapeutic class: Anti-inflammatory

Pregnancy risk category C

Action

Unclear. Reduces inflammation by suppressing polymorphonuclear leukocyte migration, reversing increased capillary permeability, and stabilizing leukocyte lysosomal membranes. Also suppresses immune response (by reducing lymphatic activity), stimulates bone marrow, and promotes protein, fat, and carbohydrate metabolism.

Availability

Elixir: 0.5 mg/5 ml

Intravitreal implant: 0.7 mg

Oral solution: 0.5 mg/5 ml, 1 mg/ml

Solution for injection (sodium phosphate): 4 mg/ml, 10 mg/ml, 20 mg/ml, 24 mg/ml

Tablets: 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, 1.5 mg, 2 mg, 4 mg, 6 mg

Indications and dosages

Macular edema following branch retinal vein occlusion or central retinal vein occlusion; noninfectious uveitis affecting posterior segment of eye

Adults: 0.7 mg by intravitreal implant

Allergic and inflammatory conditions

Adults: 0.75 to 9 mg/day (dexamethasone) P.O. as a single dose or in divided doses; in severe cases, much higher dosages may be needed. Dosage requirements vary and must be individualized based on disease and patient response.

Cerebral edema

Adults: Initially, 10 mg (sodium phosphate) I.V., followed by 4 mg I.M. q 6 hours. Then reduce dosage gradually over 5 to 7 days.

Suppression test for Cushing's syndrome

Adults: 1 mg P.O. at 11 P.M. or 0.5 mg P.O. q 6 hours for 48 hours (with urine collection testing, as ordered)

Off-label uses

• Acute altitude sickness
• Bacterial meningitis
• Bronchopulmonary dysplasia in preterm infants
• Hirsutism
• Suppression test for detection, diagnosis, or management of depression

Contraindications

• Hypersensitivity to drug, benzyl alcohol, bisulfites, EDTA, creatinine, polysorbate 80, or methylparaben
• Systemic fungal infections
• Active or suspected ocular or periocular infections, advanced glaucoma (intravitreal implant)

Precautions

Use cautiously in:
• renal insufficiency, cirrhosis, diabetes mellitus, diverticulitis, GI disease, cardiovascular disease, hypoprothrombinemia, hypothyroidism, myasthenia gravis, glaucoma, osteoporosis, infections, underlying immunosuppression, psychotic tendencies
• pregnant or breastfeeding patients
• children.

Administration

• Give P.O. dose with food or milk.
• When giving I.M., inject deep into gluteal muscle; rotate sites as needed.
• For I.V. use, drug may be given undiluted as a single dose over 1 minute or added to dextrose or I.V. saline solutions and given as an intermittent infusion at prescribed rate.

Adverse reactions

CNS: headache, malaise, vertigo, psychiatric disturbances, increased intracranial pressure, seizures

CV: hypotension, thrombophlebitis, myocardial rupture after recent myocardial infarction, thromboembolism

EENT: cataracts; elevated intraocular pressure (IOP), conjunctival hemorrhage (with intravitreal implant)

GI: nausea, vomiting, abdominal distention, dry mouth, anorexia, peptic ulcer, bowel perforation, pancreatitis, ulcerative esophagitis

Metabolic: decreased carbohydrate tolerance, hyperglycemia, cushingoid appearance (moon face, buffalo hump), decreased growth (in children), latent diabetes mellitus, sodium and fluid retention, negative nitrogen balance, adrenal suppression, hypokalemic alkalosis

Musculoskeletal: muscle wasting, muscle pain, osteoporosis, aseptic joint necrosis, tendon rupture, long bone fractures

Skin: diaphoresis, angioedema, erythema, rash, pruritus, urticaria, contact dermatitis, acne, decreased wound healing, bruising, skin fragility, petechiae

Other: facial edema, weight gain or loss, increased susceptibility to infection, hypersensitivity reactions

Interactions

Drug-drug.Barbiturates, phenytoin, rifampin: decreased dexamethasone effects

Digoxin: increased risk of digoxin toxicity

Ephedrine: increased dexamethasone clearance

Estrogen, hormonal contraceptives: blocking of dexamethasone metabolism

Fluoroquinolones: increased risk of tendon rupture

Itraconazole, ketoconazole: increased dexamethasone blood level and effects

Live-virus vaccines: decreased antibody response to vaccine, increased risk of adverse reactions

Loop and thiazide diuretics: additive hypokalemia

Nonsteroidal anti-inflammatory drugs: increased risk of GI adverse effects

Somatrem, somatropin: decreased response to these drugs

Drug-diagnostic tests.Calcium, potassium: decreased levels

Cholesterol, glucose: increased levels

Nitroblue tetrazolium test: false-negative result

Drug-herbs.Echinacea: increased immune-stimulating effect

Ginseng: potentiation of immunemodulating response

Drug-behaviors.Alcohol use: increased risk of gastric irritation and GI ulcers

Patient monitoring

• Monitor blood glucose level closely in diabetic patients receiving drug orally.
• Monitor hemoglobin and potassium levels.
• Assess for occult blood loss.

In long-term therapy, never discontinue drug abruptly. Dosage must be tapered gradually.
• Monitor patient for increased IOP after intravitreal injection.

Patient teaching

Instruct patient to immediately report sudden weight gain, swelling of face or limbs, excessive nervousness or sleep disturbances, excessive body hair growth, vision changes, difficulty breathing, muscle weakness, persistent abdominal pain, or change in stool color.
• Tell patient to take oral drug with or after meals.
• Advise patient to report vision changes and if eye becomes red, sensitive to light, or painful after intravitreal implant, to promptly report this to ophthalmologist.
• Inform patient that drug makes him more susceptible to infection. Advise him to avoid crowds and exposure to illness.

Caution patient not to stop taking drug abruptly.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

References in periodicals archive ?
Dexamethasone Sodium Phosphate Injection is used to treat various conditions like severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders and skin diseases.
Przybyl, President and CEO of Akorn and Member Manager of Akorn-Strides, LLC, "We are excited to announce these two ANDA product approvals for Dexamethasone Sodium Phosphate Injection.
PLEASE NOTE: This voluntary recall, initiated on March 16, 2011 to the User Level, is for ALL unexpired lots of all 3 sizes of Dexamethasone Sodium Phosphate Injection, USP.
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 30 mL Multiple Dose Vials with the above lot #'s for patient care and should immediately quarantine any product for return.
The Company currently markets two products, an iontophoretic system for the delivery of dexamethasone sodium phosphate, which is used in the treatment of acute local inflammation, and an iontophoretic system for the delivery of Iontocaine(TM), the Company's proprietary drug used for local dermal anesthesia.
Tenders are invited for Supply of Dexamethasone Sodium Phosphate 4Mg/Ml Inj 2Ml Vial